BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790148 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14994
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A QUESTION AS TO WHETHER THERE WAS ATRIAL OVERSENSING AND UNDERSENSING WITH THE ATRIAL LEAD AS THERE WAS ERRATIC ATRIAL PACING NOTED ON THE ELECTROGRAM (ECG) STRIPS. IT WAS NOTED THAT THE STRIPS WERE TAKEN WHILE THE PATIENT WAS IN THE SUPINE POSITION. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD WAS DETERMINED TO BE UNDERSENSING. THEREFORE THE ATRIAL LEAD SENSITIVITY WAS ADJUSTED AND THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD